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Scientist, Analytical Development

Company: Revance
Location: Newark
Posted on: January 12, 2021

Job Description:

DescriptionPosition SummaryThe Scientist, Analytical Development will be part of a team responsible for all aspects of, developing, qualifying and executing advanced technical methodologies within Analytical Development Department. The Scientist will provide role appropriate class leading, current, science-driven, phase appropriate analytical development to support clinical programs to commercial registration and post approval improvements for Revance projects.This position is a technical laboratory-based position requiring development, qualification and use of advanced Analytical methodology and working in a collaborative manner with peers in the QC Department, and across other technical groups. The role requires working knowledge of GXP regulation.Essential Duties/ResponsibilitiesServe as a competent Analytical Development scientist of the company, internally, within collaboration and potentially with CMO---s and to US FDA and other regulatory agencies to ensure Revance is appropriately represented in technical and compliance mattersDevelop, validate and execute technical analytical methodologiesUtilize complex analytical equipment and associated computer control systemsEstablish operation collaboratively with QC and R&D groupsBe part of the team that establishes, maintains and improves technical operations and project outcomes in the Analytical Development areaWork well with a team and work collaboratively across all Laboratory OperationsSupport projects for phase appropriate in-process and release methodologiesExecute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulationsEnsure adherence to GMPs, GLPs, GCPs and GDPsInteract with contract manufacturers and contract testing laboratoriesProvide support for regulatory submissionsTrain other qualified staff to ensure effective execution of roles and responsibilitiesEducationMinimum Required:Bachelor of Science degree in sciences/engineeringPreferred:M.S / Ph.D. in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related filedExperienceMinimum Required:5 years of progressive experience in the biotechnology or pharmaceutical industryKnowledge, Skills and AbilitiesMinimum Required:Analytical Development Expertise in Biologics.Knowledge, experience and skills in SEC, RP-HPLC, IEX, CE-SDS and mass spectrometry for Biologics; experience in ELISA based assays is a plusGXP regulatory experienceExperience developing, validating and executing advanced analytical methodologiesExperience in analytical sciences supporting early and late stage clinical and commercial productsCommitment to purpose and good communication skillsWorking knowledge of statisticsPreferred:Have experience of accomplishment in Analytical Development and Biosimilars, as demonstrated by successful regulatory approvals of drug candidates incorporating his/her workBe able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful executionPossess strong communication skillsBe a self-confident, proactive and driven scientist

Keywords: Revance, Newark , Scientist, Analytical Development, Other , Newark, California

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